Manager, Qualified Person and Quality Assurance - Israel
Remote · Israel
Job Summary
Lead and oversee GMP/GDP compliance and quality assurance activities in Israel for BeOne Medicines Israel. Responsible for releasing/rejecting batches of medicinal products, maintaining QMS documentation, reviewing QA agreements, handling quality complaints and recalls, managing deviations and CAPAs, supporting change control, supplier qualification and audits, and facilitating regulatory inspections. Supervises QA staff (QP) and collaborates with stakeholders domestically and internationally, staying current with MOH guidelines and global standards. Involves artwork-related support, PQRs and full batch records review, risk management planning, and maintaining quality documentation in accordance with MOH requirements; strong leadership and proficiency in Hebrew and English are essential.
Required Qualifications
- Minimum 5 years’ experience in the pharmaceutical industry as a Qualified Person (QP) and a Quality Assurance background
- Strong knowledge of Israeli regulations and standards for GDP/GMP
- Experience interacting with the Ministry of Health (MOH)
- Proficiency in Hebrew and English
- Leadership experience: managing, coaching and mentoring BeOne staff
- Ability to work with internal and external stakeholders domestically and internationally
- Experience with quality systems, QAAs, CAPA, deviations, change control, and batch records
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